The clinical research landscape is changing and clinical trials are evolving to find new, faster and more efficient ways to bring new treatments to patients.
The NIHR has been supporting the delivery of novel, complex and innovative clinical trials over the last decade. Find out how we can support you to plan, set up and deliver your trial or study to time and target in the UK.
Complex clinical trial designs (methodologies) and innovative approaches to recruitment and delivery have the potential to improve the speed and efficiency of clinical trials, shorten drug development timelines and, ultimately, bring new treatments to patients faster. Developments in science and technology also mean that innovative clinical trials are needed to assess new medicines in different (often smaller, more specific) patient populations.
The NIHR is responding to this evolution and on this page you can discover how we are supporting the next generation of clinical trials.
Through case study content you will find out how we are advocating the adoption of the adaptive trial model, helping to realise the value of registry-facilitated research, and promoting the benefits of the platform approach, to name just a few.
Complex and innovative trial designs
The phrase ‘complex and innovative trial design’ includes, but extends further than the trial methodology or design. The complexity may also exist in the set-up, recruitment, delivery or the statistical analysis and mathematics which underpin the trial. The term should be used in its broadest sense, and not be limited to specific trial designs.
Any trial design that differs from the standard randomised controlled trial (RCT) design and delivers results more efficiently, reduces the study timeline, and maximises the knowledge gained could be described as novel or innovative.
Common examples of methodologies that are considered complex and/or innovative include:
When we talk about ‘innovative delivery’ we are focusing on the set-up and the delivery of the trial, as opposed to the design. The design may be simple or standard, but the way it is delivered may be more streamlined, efficient, quicker or more patient-friendly than what has been done before. The term should be used in its broadest sense for all approaches that present an innovative solution to trial delivery. For example, this includes research that is conducted using:
electronic patient records and data linkages
research registries and biorepositories
digital tools for electronic patient reported outcomes (ePROMs)
streamlining processes across sites
risk adaptation (e.g. virtual monitoring, proportionate Source Data Verification SDV)
The NIHR is evolving the UK’s research infrastructure to support innovative clinical trials. One of our priorities is to ensure that the NHS workforce has the knowledge and skills required to deliver the next generation of clinical trials.
We have developed an eLearning resource which is freely available to all NHS and NIHR staff (and other organisations on request) via NIHR Learn. If you are not NIHR or NHS and you would like to access this eLearning resource please get in touch using the contact form in the Quick Links section above.
Life Sciences Industrial Strategy and Sector Deals The UK Life Sciences Industrial Strategy (August 2017) and the Life Sciences Sector Deal 2(December 2018) set out the Government’s commitment to consolidate the UK as a world-leader in delivering novel and innovative trials.
Enabling clinicians and researchers to effectively conduct Complex Innovative Design cancer trials January 2020: A report, published in the British Journal of Cancer, outlines recommendations for the effective delivery of Complex Innovative Design (CID) trials in the UK and Europe. These ten recommendations for cancer trials, made by Experimental Cancer Medicine Centre (ECMC) network which is jointly funded by Cancer Research UK, NIHR, Health and Research Wales, Chief Scientist Office, Public Health Agency - Research and Development).
Remote, decentralised, virtual or hybrid? Clinical trial delivery in the UK is evolving to take trial activities to the patients, rather than using the traditional paradigm of bringing patients to a trial site.